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Upturn AI SWOT - About
RZLT 
Rezolute Inc (RZLT)
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Upturn Advisory Summary
09/16/2025: RZLT (3-star) is a STRONG-BUY. BUY since 19 days. Simulated Profits (15.92%). Updated daily EoD!
Upturn Star Rating
Moderate Performance
These Stocks/ETFs, based on Upturn Advisory, typically align with the market average, offering steady but unremarkable returns.
Number of Analysts
10 Analysts rated it
Moderately tracked stock, growing coverage, gaining market and investor attention.
1 Year Target Price $13.33
1 Year Target Price $13.33
| 7 | Strong Buy |
| 3 | Buy |
| 0 | Hold |
| 0 | Sell |
| 0 | Strong Sell |
Analysis of Past Performance
Type Stock | Historic Profit 200.1% | Avg. Invested days 35 | Today’s Advisory Strong Buy |
Upturn Star Rating | Upturn Advisory Performance  3.0 | Stock Returns Performance  5.0 |
| Profits based on simulation | Last Close 09/16/2025 |
Key Highlights
Company Size Small-Cap Stock | Market Capitalization 671.61M USD | Price to earnings Ratio - | 1Y Target Price 13.33 |
Price to earnings Ratio - | 1Y Target Price 13.33 | ||
Volume (30-day avg) 10 | Beta 0.03 | 52 Weeks Range 2.21 - 8.34 | Updated Date 09/16/2025 |
52 Weeks Range 2.21 - 8.34 | Updated Date 09/16/2025 | ||
Dividends yield (FY) - | Basic EPS (TTM) -1.16 |
Earnings Date
Report Date 2025-09-11 | When - | Estimate -0.2133 | Actual - |
Profitability
Profit Margin - | Operating Margin (TTM) - |
Management Effectiveness
Return on Assets (TTM) -52.85% | Return on Equity (TTM) -95.16% |
Valuation
Trailing PE - | Forward PE - | Enterprise Value 564743007 | Price to Sales(TTM) - |
Enterprise Value 564743007 | Price to Sales(TTM) - | ||
Enterprise Value to Revenue - | Enterprise Value to EBITDA -0.01 | Shares Outstanding 86996000 | Shares Floating 76696290 |
Shares Outstanding 86996000 | Shares Floating 76696290 | ||
Percent Insiders 9.68 | Percent Institutions 90.03 |
Upturn AI SWOT
Rezolute Inc
Company Overview
History and Background
Rezolute, Inc. is a late-stage biopharmaceutical company focused on developing novel therapeutics for metabolic diseases, including congenital hyperinsulinism (CHI) and other rare diseases. The company was founded in 2010 and has focused on developing therapies that can help children with severe, life-threatening conditions.
Core Business Areas
- Congenital Hyperinsulinism (CHI) Program: Developing RZ358, a human monoclonal antibody for the treatment of CHI, a rare genetic disorder causing dangerously low blood sugar levels in infants and children.
- RZ402 Program: Development of RZ402, an oral plasma kallikrein inhibitor for Diabetic Macular Edema (DME).
Leadership and Structure
The leadership team includes individuals with experience in pharmaceutical development and commercialization. The company operates with a typical biopharmaceutical structure, focused on research, clinical development, and regulatory affairs.
Top Products and Market Share
Key Offerings
- RZ358: RZ358 is Rezolute's lead product candidate for the treatment of CHI. Market share data is not yet available as the product is still in clinical development. Competitors include diazoxide, octreotide, and pancreatectomy, which are current standards of care. Potential competitors in future CHI therapies include other biopharmaceutical companies.
- RZ402: RZ402 is Rezolute's second product candidate for the treatment of Diabetic Macular Edema. The DME market is dominated by anti-VEGF therapies such as aflibercept (Eylea - REGN), ranibizumab (Lucentis - ROGN), and brolucizumab (Beovu - NVS). Market share data is not yet available as the product is still in clinical development
Market Dynamics
Industry Overview
The biopharmaceutical industry is characterized by high R&D costs, long development timelines, and significant regulatory hurdles. The rare disease market is particularly attractive due to orphan drug designations that provide market exclusivity and pricing power.
Positioning
Rezolute is positioned as a company focused on developing therapies for rare metabolic diseases, particularly CHI. Its competitive advantage lies in its novel approach with RZ358, potentially offering a more targeted and effective treatment compared to existing options.
Total Addressable Market (TAM)
The estimated TAM for CHI is substantial given the unmet medical need and potential for high pricing due to the rarity of the disease. TAM is difficult to quantify precisely due to limited prevalence data. The total addressable market for Diabetic Macular Edema is roughly 7 Billion USD in 2023 and expected to grow to around 10 Billion USD by 2032. Rezolute's positioning in this market will depend on the clinical trials and safety of RZ402.
Upturn SWOT Analysis
Strengths
- Novel therapeutic approach with RZ358
- Focus on rare diseases with high unmet need
- Orphan drug designation potential for market exclusivity
- Experienced management team
Weaknesses
- Reliance on a limited number of product candidates
- High cash burn rate associated with clinical development
- Regulatory and clinical trial risks
- Dependence on successful fundraising
Opportunities
- Successful clinical trials leading to regulatory approval
- Expansion into other rare metabolic diseases
- Partnerships with larger pharmaceutical companies
- Potential for high pricing due to orphan drug designation
Threats
- Clinical trial failures
- Regulatory setbacks
- Competition from other companies developing therapies for CHI
- Inability to raise sufficient capital
Competitors and Market Share
Key Competitors
- REGN
- NVS
Competitive Landscape
Rezolute faces competition from established therapies for CHI (diazoxide and octreotide) and potential competitors developing new treatments. In the DME market, it has to go up against main players like REGN and NVS, with their anti-VEGF treatment options.
Growth Trajectory and Initiatives
Historical Growth: Rezolute's historical growth is primarily measured by progress in clinical development, rather than revenue.
Future Projections: Future growth is dependent on successful clinical trials and regulatory approval of RZ358 and RZ402. Analyst estimates vary widely.
Recent Initiatives: Recent initiatives include advancing RZ358 through Phase 2b clinical trials and planning for pivotal Phase 3 studies, and continuing RZ402 through Phase 1 clinical trials.
Summary
Rezolute is a high-risk, high-reward biopharmaceutical company focused on rare diseases. Its lead product, RZ358, has the potential to address a significant unmet need in CHI. Successful clinical trials and regulatory approval are critical for the company's future growth. Investors should be aware of the significant risks associated with biopharmaceutical development, including clinical trial failures and regulatory setbacks.
Peer Comparison
Sources and Disclaimers
Data Sources:
- Company website, SEC filings, ClinicalTrials.gov, Analyst reports (where available).
Disclaimers:
This analysis is for informational purposes only and should not be considered financial advice. Investment decisions should be based on thorough research and consultation with a qualified financial advisor.
AI Summarization is directionally correct and might not be accurate.
Summarized information shown could be a few years old and not current.
Fundamental Rating based on AI could be based on old data.
AI-generated summaries may have inaccuracies (hallucinations). Please verify the information before taking action.
About Rezolute Inc
Exchange NASDAQ | Headquaters Redwood City, CA, United States | ||
IPO Launch date 2014-05-01 | Founder, CEO, Principal Financial Officer & Acting Chairman of the Board Mr. Nevan Charles Elam J.D. | ||
Sector Healthcare | Industry Biotechnology | Full time employees 68 | Website https://www.rezolutebio.com |
Full time employees 68 | Website https://www.rezolutebio.com | ||
Rezolute, Inc., a late-stage rare disease company, focused on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism in the United States. The company's lead product candidate is ersodetug, a human monoclonal antibody that is in Phase 3 clinical trial for the treatment of congenital hyperinsulinism, an ultra-rare pediatric genetic disorder. It also developing RZ402, an oral plasma kallikrein inhibitor, which is in Phase 2 clinical trial for the chronic treatment of diabetic macular edema. The company was formerly known as AntriaBio, Inc. and changed its name to Rezolute, Inc. in December 2017. Rezolute, Inc. was incorporated in 2010 and is headquartered in Redwood City, California.
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